The Effects of Omalizumab (Anti-IgE) on the Late-phase Response to Nasal Allergen Challenge

February 24, 2014 updated by: Sarbjit Saini, Johns Hopkins University

The Effects of Omalizumab on the Late-phase Response to Nasal Allergen Challenge

This research is being done to study the effects of the drug omalizumab (Xolair) in people with cat allergies. The investigators will use omalizumab to study changes in the cells in the nose, cells in the blood and cells in the skin that cause allergies. The investigators will compare the changes in the nose to changes in the skin and blood cells.

Objective: To test the hypothesis that treatment with omalizumab will decrease the nasal allergen challenge late-phase eosinophil count in nasal brushings at the time when blood basophils have become hypo-responsive to in vitro allergen exposure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized, placebo-controlled, double-blind, parallel group design study that includes 3.5 months of treatment with omalizumab or placebo and a 3 month follow-up. All subjects will be cat allergic.

Twenty four subjects (1:1 randomization) will undergo a cat allergen nasal challenge prior to treatment and another challenge after 2 months of treatment or when their blood basophils become hyporesponsive to cat allergen in vitro. A second group of 10 subjects (1:1 active:placebo), will not undergo nasal challenges. This group will participate in an ancillary study in which the effects of omalizumab on gene expression profiles in peripheral blood cells will be studied.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins Asthma and Allergy Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion criteria:

  1. Male or female, ages 18-50
  2. Females must be surgically sterile or postmenopausal or using a specified acceptable form of birth control throughout the duration of the study. Females in certain categories (not sexually active, vasectomized partner) will be admitted at the discretion of the investigator on a case-by-case basis.
  3. Females must have a negative urine pregnancy test at Visit A and other visits specified in this protocol.
  4. Clinical history of perennial allergic rhinitis for at least two years, with or without seasonal allergic rhinitis, and with or without mild persistent asthma as define by the 2007 NAEPP guidelines.
  5. Allergic cat sensitization defined by a positive puncture skin test (mean wheal diameter 3 mm or more greater than diluent control), and a positive CAP-RAST to cat > 0.35 kU/L.
  6. Positive intranasal cat allergen challenge defined by the induction of a total of ≥ 5 sneezes at screening(criterion not applicable in the ancillary study).
  7. Baseline in vitro histamine release of peripheral blood basophils to cat allergen ≥7%.
  8. Peripheral blood basophils > two million per 100 ml of blood (criterion only applicable in the ancillary study)

Exclusion Criteria:

  1. Asthma with baseline FEV1 < 80% predicted, and/or moderate to severe asthma classification per the 2007 NAEPP guidelines.
  2. Individuals with total serum IgE levels less than 30 IU/mL or greater than 700 IU/mL at the time of enrollment.
  3. Individuals with reduced hematocrit (< 32%), WBC count (2400/microliter), platelet count (< 75000/microliter), and increased creatinine (> 141.4 micromolar/L), or AST (> 100 IU/L).
  4. Individuals with body weight less than 30 kg or greater than 150 kg.
  5. Pregnant females or females with plans to become pregnant or breastfeed during the duration of the study.
  6. Individuals with perforated nasal septum, structural nasal defects, large nasal polyps causing obstruction, evidence of acute or chronic sinusitis.
  7. History of malignancy, anaphylaxis or bleeding disorder.
  8. Mental illness or history of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements.
  9. Inability or unwillingness of a participant to give written informed consent or comply with study protocol.
  10. Use of any investigational drugs within 8 weeks of participation.
  11. Contraindications to omalizumab including patients with a previous hypersensitivity to omalizumab.
  12. Recent recipient of any licensed or investigational live attenuated vaccine(s) within two months of study initiation such as flu mist.
  13. Any prior use of omalizumab.
  14. Frequent episodes of acute sinusitis (>2 documented episodes per year) or active sinusitis within 2 weeks prior to enrollment
  15. Use of aeroallergen immunotherapy within 5 years prior to enrollment
  16. Current or within 4 weeks prior to enrollment use of nasal steroids, nasal cromolyn or oral steroids
  17. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or may compromise the quality

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Omalizumab
Active treatment: Experimental This arm will receive treatment with omalizumab at the dose FDA-approved for the treatment of allergic asthma.
Drug: Omalizumab
Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks.
Other Names:
  • Xolair
  • Anti-IgE
PLACEBO_COMPARATOR: Placebo
This arm will receive treatment with a placebo injections based on the FDA-approved dosing schedule approved for omalizumab for the treatment of allergic asthma.In general injection number and frequency are determined by a subject's weight and IgE level.
Drug: Placebo
Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The the Size of the 8 Late-phase Skin Response
Time Frame: Baseline, 2-6 wks
Reduction in skin late phase size at 8 hours at the time of blood basophil hypo-responsiveness to allergen will be reduced compared to baseline.
Baseline, 2-6 wks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)
Genentech, Inc.

Investigators

  • Principal Investigator: Sarbjit Saini, MD, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

September 1, 2013

Study Registration Dates

First Submitted

October 27, 2009

First Submitted That Met QC Criteria

October 27, 2009

First Posted (ESTIMATE)

October 28, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

April 7, 2014

Last Update Submitted That Met QC Criteria

February 24, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NA_00027984
  • U19AI070345 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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